Microelectrodes in Epilepsy

• Sponsor: Dartmouth-Hitchcock Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT05200455
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arm: 1
• Actual Duration (Months): 140
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to test microelectrodes in intracranial monitoring to see if they will provide novel information on the epileptic potential of the implanted brain tissue. A secondary objective is to investigate the activity of single neurons during specific cognitive tasks.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy	Device: Microelectrodes	N/A

Detailed Description

The standard-of-care for medically refractory epilepsy is resective brain surgery. In certain patients, precise localization of the epileptic focus is done using intracranial EEG (iEEG) recording. In this type of EEG recording, electrodes are placed on the brain surface or inserted into the brain through an opening in the skull. In addition to standard electrode recording, this study will use ultra thin microelectrodes. Microelectrodes are only several micrometers thick and are useful because they are able to record the activity of single neurons in isolation. Such recordings have tremendous clinical potential in epilepsy surgery and tremendous research potential in cognitive neuroscience.

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Microelectrodes in Epilepsy
• Actual Study Start Date: Sep 18, 2009
• Actual Primary Completion Date: Mar 30, 2021
• Actual Study Completion Date: May 18, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Microelectrodes Patients who qualify for this study will be implanted with standard electrodes as well as microelectrodes for their intracranial seizure monitoring.	Device: Microelectrodes; Microelectrode implantation

Outcome Measures

Primary Outcome Measures

1. Localize the epileptic focus [Evaluated for each patient during monitoring period of approximately 2 weeks]

   Measure the occurrence of high oscillations (fast ripples) in epileptogenic cortex and in non-epileptogenic cortex focus to identify the location of the epileptic focus.

Secondary Outcome Measures

1. Correlate single unit activity recorded from various electrode positions in the brain with specific cognitive tasks [Evaluated for each patient during monitoring period of approximately 2 weeks]

   Record neuronal discharge characteristics from single neurons during cognitive tasks

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18-65 year old

• male or female

• right or left handed

• IQ>70

• medically refractory focal epilepsy requiring intracranial EEG for pre-surgical evaluation deemed medically necessary

• no contraindications to intracranial electrode study

• able and willing to participate in research

Exclusion Criteria:

• does not meet the inclusion criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756

Sponsors and Collaborators

• Dartmouth-Hitchcock Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Barbara Jobst, Chair, Department of Neurology, Dartmouth-Hitchcock Medical Center
• ClinicalTrials.gov Identifier: NCT05200455
• Other Study ID Numbers: STUDY00021993
• First Posted: Jan 20, 2022
• Last Update Posted: Jan 20, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Epilepsy

Study Results

No Results Posted as of Jan 20, 2022